Clinical Trials Directory

Trials / Completed

CompletedNCT03271463

Assessing Leg Control in People With Chronic Stroke

Lower Extremity Selective Voluntary Motor Control in Adults With Chronic Stroke: Comparing the SCALE Assessment to the Fugl-Meyer Assessment

Status
Completed
Phase
Study type
Observational
Enrollment
16 (actual)
Sponsor
University of Minnesota · Academic / Other
Sex
All
Age
18 Years – 79 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to compare the clinometric (psychometric) properties of the SCALE and FMA-LE assessments in adults after stroke. A second purpose is to determine how well each measure predicts walking speed using the 10 meter walk test.

Detailed description

Selective voluntary motor control may be important in prognosticating future function in adults post stroke. It is therefore important to measure selective voluntary motor control using assessments that are valid, reliable and easy to perform and interpret. Current assessments are time consuming and complicated. Clinicians who work with patients post stroke will benefit from this research because they will have evidence supporting appropriate measurement of selective voluntary motor control. This evidence may inform their clinical decision making when working with patients. Patients who have survived a stroke will benefit because their therapists will be able to better measure their selective voluntary motor control which may one day lead to better prediction of functional outcomes and the selection of appropriate interventions. The Fugl-Meyer assessment (FMA) is the "Gold Standard" for the assessment of individuals with brain injury, most commonly those surviving cerebrovascular accident (stroke). The full assessment is complicated and can take more than an hour to complete. Clinicians have limited time to perform a full evaluation of their patients, the FMA is just one part of this evaluation. The lower extremity selective voluntary motor control component of the FMA (FMA-LE) is difficult for clinicians who are not experts to perform and interpret. For these reasons, few practicing clinicians use the FMA. However, measuring selective voluntary motor control may be important for prognosticating patients' future functional level and their need for continued therapeutic interventions. The Selective Control Assessment of Lower Extremity (SCALE) was developed for use with children who have cerebral palsy (CP), a condition that in some ways presents similar to stroke. The SCALE has been validated and deemed reliable in the pediatric population with CP. This study aims to determine inter-rater and intra-rater reliability for the FMA-LE and the SCALE. In addition, scores on the SCALE will be compared to scores on the FMA-LE to determine concurrent validity. Finally the scores on the SCALE and FMA-LE will be compared to the time it takes for stroke survivors to walk 10-meters (10-meter walk test) to determine how well each measure predicts functional status (predictive validity).

Conditions

Interventions

TypeNameDescription
BEHAVIORALSelective Control Assessment of Lower Extremity (SCALE)Inter- and intra-rater reliability Validity: correlation analysis with Fugl-Meyer Assessment - Lower Extremity Component (FMA-LE) and 10 meter walk test (see below)

Timeline

Start date
2018-08-05
Primary completion
2020-11-05
Completion
2020-11-05
First posted
2017-09-05
Last updated
2021-04-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03271463. Inclusion in this directory is not an endorsement.